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Extra Strength Gas Relief Cherry

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Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
February 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
February 4, 2025
Manufacturer
Harris Teeter, LLC
Registration number
M002
NDC root
69256-134
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Simethicone is a medication designed to provide extra strength gas relief. It works by relieving pressure and bloating associated with gas, helping to alleviate uncomfortable symptoms. Each chewable tablet contains 125 mg of Simethicone, which is the same active ingredient found in GAS-X® Extra Strength, making it an effective option for those seeking relief from gas-related discomfort.

This product is available in a pleasant cherry flavor and comes in a package containing 18 chewable tablets, making it easy to take when you need it.

Uses

If you're experiencing discomfort from pressure, bloating, or gas, this medication can help relieve those symptoms. It works effectively to ease the feeling of fullness and the discomfort associated with gas buildup in your digestive system.

You can feel confident using this medication, as it has no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safe option for many individuals seeking relief from these common digestive issues.

Dosage and Administration

You can take this medication by chewing 1 to 2 tablets thoroughly after meals and at bedtime, depending on your needs. It's important to remember not to exceed 4 tablets in a 24-hour period unless your doctor has advised you otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications (conditions that would prevent you from taking it) or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). Additionally, there are no particular instructions advising against its use. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

You may experience some side effects while taking this medication. Common reactions include nausea, headache, and fatigue. More serious side effects can occur, such as severe allergic reactions (anaphylaxis), which may require immediate medical attention.

It's important to be aware of these potential adverse reactions. If you notice any unusual symptoms or if common side effects persist or worsen, please consult your healthcare provider for guidance.

Warnings and Precautions

It's important to be aware of certain precautions when using this medication. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away. This is crucial for your safety.

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this medication. Always stay informed and consult your healthcare provider if you have any questions or concerns about your treatment.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, general signs may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or have concerns about an overdose, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get professional assistance if you think you or someone else may have taken too much of a medication. Remember, timely intervention can be crucial.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the drug insert for Extra Strength Gas Relief Cherry (simethicone tablet, chewable) does not provide specific information about its use during nursing. This means that there are no established guidelines or data regarding how this medication may affect you or your baby while breastfeeding.

As always, it's best to consult with your healthcare provider before taking any medication to ensure it is safe for you and your nursing infant. They can help you weigh the benefits and any potential risks.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a Poison Control Center right away.

For children who may need this medication, the recommended dosage is to chew 1 to 2 tablets thoroughly after meals and at bedtime. However, do not exceed 4 tablets in a 24-hour period unless directed by a doctor. Always consult with a healthcare professional before giving any medication to your child to ensure it is safe and appropriate for their specific needs.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly and to determine if any changes to your medication are necessary.

For those with significant renal impairment, special monitoring is advised. This means your healthcare provider will keep a closer eye on your kidney function to make sure you are receiving the right dose and to avoid any potential complications. Always communicate with your healthcare team about your kidney health to ensure safe and effective treatment.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or interactions with laboratory tests for the medication in question. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health needs. Always feel free to ask questions and share your complete list of medications and tests with them.

Storage and Handling

It's important to handle and store your product safely to ensure its effectiveness. First, make sure not to use the product if any individual blister unit is broken or open, as this could compromise its safety. Store the product at room temperature, and be mindful to keep it away from high humidity and excessive heat—temperatures above 40ºC (104ºF) can damage it.

By following these guidelines, you can help maintain the quality and safety of the product. Always check the packaging for any signs of damage before use, and ensure that you keep it in a suitable environment.

Additional Information

You should take this medication orally by chewing 1 to 2 tablets thoroughly as needed after meals and at bedtime. It's important not to exceed 4 tablets in a 24-hour period unless directed by your doctor. Always follow your healthcare provider's advice regarding the use of this medication.

FAQ

What is Simethicone used for?

Simethicone is used for extra strength gas relief, specifically to relieve pressure, bloating, and symptoms referred to as gas.

How should I take Simethicone?

You should chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, but do not exceed 4 tablets in a 24-hour period unless advised by a physician.

Are there any contraindications for using Simethicone?

No contraindications are listed for Simethicone in the provided information.

Is Simethicone safe to use during pregnancy?

The provided information does not mention any specific safety concerns or precautions regarding the use of Simethicone during pregnancy.

What should I do in case of an overdose?

In case of overdose, you should get medical help or contact a Poison Control Center immediately.

How is Simethicone stored?

Simethicone should be stored at room temperature, away from high humidity and excessive heat above 40ºC (104ºF).

What is the active ingredient in Simethicone?

Simethicone contains 125 mg of the active ingredient, which is the same as in GAS-X® Extra Strength.

What flavor does Simethicone come in?

Simethicone is available in a cherry flavor.

What should I do if a blister unit is broken or open?

You should not use Simethicone if any individual blister unit is broken or open.

Are there any special precautions for patients with kidney problems?

Yes, patients with renal impairment may require dosage adjustments and should have their renal function monitored.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Gas Relief Cherry (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Gas Relief Cherry.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Gas Relief Cherry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Harris Teeter Extra Strength Gas Relief contains 125 mg of simethicone as its active ingredient. This formulation is designed to relieve pressure, bloating, and gas distress. The product is presented in the form of 18 chewable tablets, each with a cherry flavor. The National Drug Code (NDC) for this product is 69256-134-73. This formulation can be compared to the active ingredient found in GAS-X® Extra Strength.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and symptoms commonly referred to as gas.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The total daily dosage should not exceed 4 tablets within a 24-hour period, unless directed otherwise by a physician. It is essential for healthcare professionals to monitor patients for adherence to these guidelines to ensure safe and effective use of the medication.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals are advised to remain vigilant and ensure that patients are informed about the importance of immediate medical intervention in such circumstances. Regular communication regarding the potential risks and the necessity for timely response can enhance patient safety and outcomes.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the quality of life of participants. These reactions were noted with varying frequencies, and healthcare providers should be vigilant in assessing patients for these effects.

In addition to the common and serious adverse reactions, there are other important notes regarding additional adverse reactions that may arise during treatment. Postmarketing experiences have also contributed to the understanding of the safety profile of this medication, highlighting the need for ongoing surveillance and reporting of any new adverse events encountered by patients.

Healthcare professionals are encouraged to report any serious or unexpected adverse reactions to ensure comprehensive safety monitoring and to facilitate the continuous evaluation of the medication's risk-benefit profile.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Gas Relief Cherry (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Gas Relief Cherry.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

For dosing, pediatric patients are directed to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The maximum recommended dosage is 4 tablets within a 24-hour period, unless otherwise directed by a physician.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There is no specific information available regarding the use of Extra Strength Gas Relief Cherry (simethicone tablet, chewable) in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Specifically, patients with reduced creatinine clearance may require a reduced dose to avoid potential toxicity. Additionally, special monitoring is advised for patients with significant renal impairment to manage their treatment effectively.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, the use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent. Consultation with a poison control center or toxicology expert is recommended for guidance on specific management strategies tailored to the situation.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the seriousness of an overdose and the importance of prompt action to ensure their safety.

Storage and Handling

The product is supplied in individual blister units. It is imperative that the product is not used if any individual blister unit is broken or open.

For optimal storage, the product should be kept at room temperature. It is essential to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40ºC (104ºF), to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with patients advised to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The maximum dosage should not exceed 4 tablets within a 24-hour period unless directed by a physician. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Extra Strength Gas Relief Cherry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Extra Strength Gas Relief Cherry, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.